Justification for Nonmaterial Change 0502

Justification for Nonmaterial/Non-Substantive Change

OMB Control No. 0910-0502

Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

FDA is requesting approval of revised FDA Form 3537, “DHHS/FDA Food Facility Registration.” The revised form reflects modifications made to accommodate new data elements introduced by the Food Safety and Modernization Act (FSMA) and as discussed in the supporting statement. FDA inadvertently uploaded and provided the outdated, and thus incorrect, version of the reporting form to OMB for its review. This transmission provides the revised version of FDA Form 3537, the version FDA intends to deploy for this information collection.